Gur­net Point-backed Au­re­gen taps Am­gen vet to lead; Ex-Roche RNA chief takes CEO post at Genevant

Gur­net Point Cap­i­tal-backed Au­re­gen Bio­Ther­a­peu­tics has tapped Am­gen vet Richard Davies to lead its rare dis­ease cell ther­a­py’s en­try in­to the clin­ic as CEO. Davies, a for­mer Hos­pi­ra chief com­mer­cial of­fi­cer who had his first chief ex­ec­u­tive ex­pe­ri­ence re­cent­ly at Bone­sup­port, will lead the dri­ve in trans­lat­ing the Gene­va-based biotech’s 3D bio­fab­ri­ca­tion tech­nolo­gies to new ther­a­peu­tics, start­ing from a pro­gram in rare con­gen­i­tal cran­io­fa­cial dis­or­ders.

→ Brick­ell Biotech has hired in­dus­try vet­er­an and Lil­ly $LLY Chief Mar­ket­ing Of­fi­cer Robert Brown to take the reins at the der­ma­tol­ogy com­pa­ny as it preps a late-stage tri­al eval­u­at­ing its drug, sof­piro­ni­um bro­mide, in pa­tients with ex­ces­sive un­der­arm sweat­ing in the first half of 2019. Brown, who has spent over three decades at Lil­ly, is set to re­place Brick­ell’s cur­rent CEO and co-founder Regi­nald Hardy on Jan­u­ary 1.

Bo Rode Hansen is step­ping up from a CSO po­si­tion to take the top job at Genevant. Un­like the rest of Vivek Ra­maswamy’s biotech fam­i­ly, the com­pa­ny is not in-li­cens­ing late-stage pro­grams, but build­ing a pipeline from scratch us­ing Ar­bu­tus’ RNA tech, with the aim of de­liv­er­ing more than five in-house and part­nered can­di­dates for clin­i­cal de­vel­op­ment by 2020. Hansen, the for­mer glob­al head of RNA at Roche with 50 dis­cov­ery pro­grams un­der his belt, will play a lead­ing role along­side a sea­soned ex­ec team.

→ A year af­ter Mary Szela left the helm of Nov­e­l­ion Ther­a­peu­tics $NVLN, the rare dis­ease biotech is shak­ing up its CEO of­fice again. Jef­frey Hack­man, the for­mer COO who’s been fill­ing in, has re­signed as in­ter­im CEO, pass­ing the re­spon­si­bil­i­ties to gen­er­al coun­sel Ben­jamin Harsh­barg­er. Hav­ing helped se­cure a re­cent loan fa­cil­i­ty, Harsh­barg­er is charged with the grand turn­around mis­sion by first fix­ing the cap­i­tal struc­ture.

→ Al­most a year af­ter step­ping down from Syn­er­gy Phar­ma­ceu­ti­cals — a com­pa­ny he found­ed and co-in­vent­ed the lead drug for — Gary Ja­cob has land­ed at a mi­cro­bio­me biotech in Aus­tralia. As CEO, Ja­cob is ex­pect­ed to chan­nel both his de­vel­op­ment, fi­nan­cial and com­mer­cial ex­per­tise in steer­ing Im­muron’s $IM­RN pipeline of oral­ly de­liv­ered poly­clon­al an­ti­bod­ies, which is led by a pro­gram for liv­er dis­eases.

→ Fol­low­ing a wide-rang­ing ca­reer fea­tur­ing stints at No­var­tis, L’Ore­al and SBM Man­age­ment Ser­vices, Stephan Jack­man has been ap­point­ed CEO of Alza­mend Neu­ro, a biotech de­vel­op­ing a cou­ple of Alzheimer’s drug can­di­dates out of the Uni­ver­si­ty of South Flori­da. Pri­or to the new role, Jack­man was fo­cused on ad­vanc­ing cures for mos­qui­to borne in­fec­tious dis­eases as COO of En­naid Ther­a­peu­tics.

→ New­ly pub­lic Ma­gen­ta Ther­a­peu­tics $MG­TA has scooped Ja­son Ryan from Foun­da­tion Med­i­cine to be its chief op­er­at­ing and fi­nan­cial of­fi­cer. The high fly­ing Cam­bridge start­up, which has a port­fo­lio fo­cused on bone mar­row trans­plant, can ben­e­fit from Ryan’s ex­pe­ri­ence in cap­i­tal cre­ation and al­lo­ca­tion as well as com­mer­cial plan­ning, says CEO Ja­son Gard­ner, as demon­strat­ed in his ef­forts with Foun­da­tion’s re­cent sale to Roche.  

→ Gothen­burg, Swe­den-based Iso­fol has hired Roger Tell — a bio­phar­ma vet who’s al­so run mul­ti­ple tri­als as a prin­ci­pal in­ves­ti­ga­tor — to run its clin­i­cal pro­gram as it ad­vances its lead prod­uct can­di­date in­to Phase III. Ar­foli­tixorin, de­vel­oped through a part­ner­ship with Mer­ck KGaA, is de­signed to boost the ef­fects of chemother­a­py main­ly in col­orec­tal can­cer. As CSO and SVP of clin­i­cal de­vel­op­ment, Tell will al­so over­see  sci­en­tif­ic re­search and tech­ni­cal op­er­a­tions.

→ With its Phase III pro­grams well un­der­way, Apel­lis Phar­ma­ceu­ti­cals $APLS has tapped Adam Townsend to plot a mar­ket­ing plan for APL-2 — its com­ple­ment C3 in­hibitor look­ing to ri­val Soliris in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria — and al­so build a fran­chise in ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion. The new chief com­mer­cial joins from Bio­gen, where he helped lead the launch­es of Tec­fidera and Spin­raza.

→ Fol­low­ing an 11-year ca­reer run­ning clin­i­cal op­er­a­tions for mul­ti­ple units — in­clud­ing the oph­thalmic fran­chise — at No­var­tis, Fabio Baschiera is jump­ing to an oph­thal­mol­o­gy start­up backed by the phar­ma gi­ant. His new ti­tle at Oculis will be VP of clin­i­cal de­vel­op­ment. Al­so join­ing the Swiss biotech: Louie-Anne Gau­thi­er, who will now scout deals for Oculis’ eye drop al­ter­na­tives for in­jectable drugs as its VP of strate­gic mar­ket­ing, busi­ness de­vel­op­ment and li­cens­ing.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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